Heparin-Induced Thrombocytopenia Registry (HIT)

This study has been completed.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00456326
First received: April 2, 2007
Last updated: February 12, 2008
Last verified: February 2008
  Purpose

The purpose of the Heparin Induced Thrombocytopenia Registry is to explore the frequency of heparin-induced thrombocytopenia (HIT) at Brigham and Women's Hospital and to assess its mortality rate. Retrospective 3 years, looking forward prospectively.


Condition
Heparin-Induced Thrombocytopenia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A 3 Year Retrospective Heparin Induced Thrombocytopenia Registry (HIT) at Brigham and Women's Hospital.

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Incidence of HIT associated with UFH and LMWH [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Outcomes of patients with HIT [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Adverse events associated with alternative anticoagulants used to treat HIT [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Hemorrhagic Events [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Thrombotic Events [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: October 2005
Study Completion Date: August 2007
Groups/Cohorts
HIT Patients
Patients at Brigham and Women's Hospital diagnosed with Heparin Induced Thrombocytopenia.

Detailed Description:

Heparin-induced thrombocytopenia (HIT) is an immune-mediated adverse drug reaction with potentially fatal complications of venous and arterial thrombosis.

HIT with thrombosis causes prolonged hospital length of stay and is associated with catastrophic outcomes such as extremity amputation as well as death. The fear of HIT has led to some proposals to minimize hospital use of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) and to substitute other anticoagulants that have not been reported to cause HIT. Therefore, the frequency of confirmed HIT and the frequency of determining whether UFH or LMWH is the causative agent urgently require further investigation.

At BWH, we have placed patient safety at a premium. We have a Patient Safety Committee and a Patient Safety Officer. HIT has been identified as one of the primary problems requiring urgent policy decisions. Consequently, we have formed a multi-disciplinary team of physicians, pharmacists, nurses and physician's assistants to improve safe medication practices for patients receiving anticoagulation.

Our primary objectives are to establish an HIT registry which will provide information on:

  1. Incidence of HIT associated with UFH and LMWH
  2. Outcomes of patients with HIT
  3. Adverse events associated with alternative anticoagulants used to treat HIT

We will obtain data with respect to: Drug, Dose, Route of administration, Duration of therapy, Platelet count, Platelet nadir, Co-morbidities (Coronary Artery Disease, Diabetes Mellitus, Myocardial Infarction, Hypertension, Pulmonary Disease, Chronic Renal Failure, Malignancy, Liver Disease, Surgery, Sepsis), Baseline characteristics (Age, Sex, Weight), Pregnancy status, Serum Creatinine, AST, ALT, Hematocrit, Hemoglobin, Venous and Arterial Thrombotic events (DVT, PE, CVC), 30-day mortality rate, alternative anticoagulant therapy, and duration of therapy.

Time and Method of Data Collection:

Chart Review for the duration of hospitalization: Hemorrhagic event, Thrombotic events, and 30-day Mortality Rate.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with Heparin Induced Thrombocytopenia

Criteria

All patients hospitalized at BWH who have a PF4-Positive antibody test

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456326

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Samuel Z. Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00456326     History of Changes
Other Study ID Numbers: 2005-P-001941
Study First Received: April 2, 2007
Last Updated: February 12, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Heparin
Unfractionated Heparin
Low Molecular Weight Heparin
Anticoagulation
Thrombocytopenia
Thrombosis
Venous Thrombosis
Pulmonary Embolism

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014